Rain Therapeutics is committed to building a passionate team of core business leaders to execute on our vision to identify, and execute on the development, of novel therapeutic avenues for the treatment of cancer. The personality of Rain will always be focused on entrepreneurs with autonomy to build their respective teams in a flat organizational structure.
The Chief Medical Officer position will assume a leadership, as well as a hands-on, role in the strategic planning, implementation, and oversight of clinical trials, reporting and potential registration of one or more therapeutic candidates. Specialty training and certification in oncology is required. Candidate should be board certified with specialty training and certification with relevant experience in drug development within the pharmaceutical or biotech industry. Strong background and interest in the underlying science and mechanism of action of therapeutics is required. Prior experience in translational research strongly preferred.
Candidate will be responsible for designing and working closely with all functions to enable clinical development goals and deliverables as well as implementation and medical monitoring of clinical trials in early and late stage development. Candidate will be responsible for providing clinical leadership to the program team, clinical operations and other functional groups within clinical development. The clinical operations, safety, regulatory and biostats teams will report into the Chief Medical Officer position.
- Board certified/eligible MD with specialty training and certification in oncology is required
- At least three (3) years of prior experience as a Chief Medical Officer in an oncology-focused small-mid cap biotech company
- Must have experience with US regulatory filings. Experience with ex-US regulatory filings is desirable
Critical Job Skills:
- Provide primary tactical and strategic clinical/medical leadership for one or more development programs
- Responsible for clinical development plans, including outlining strategic goal of a targeted patient strategy, potential of identifying patients based on diagnostic technologies, key competitive challenges in the therapeutic area and writing clinical study protocols
- Liaise directly with regulatory agencies
- Serve as the primary medical monitor for all clinical trials, with oversight of third-party CRO medical monitors and service providers
- Responsible for oversight of medical safety monitoring for sponsored clinical trials. Works closely with Drug Safety and Biometrics functions to ensure that data output is planned and ready for periodic Data Monitoring Committee reviews and internal data monitoring
- Experience with Good Clinical Practices (GCPs) and need for compliance with standard operating procedures (SOPs) and systems
- Work effectively with other functional area personnel toward the development of regulatory strategies and clinical trial execution that lead to product registration
- Work effectively with Program Management, Clinical Operations and Regulatory Affairs to align on current and projected clinical development deliverables to ensure timely trial execution that leads to product registration.
- Interact successfully with research/discovery, and CMC groups to delineate and enable deliverables in support of the development strategy
- Assist in the evaluation of external compounds for in-licensing and / or preparations / presentations for potential partnering activities
- Excellent communication, interpersonal and presentation skills and ability to present concepts and clinical trial results to a variety of audiences, including medical and scientific peers, Board of Directors, advisory boards, company and department personnel
- Assists in preparation of Clinical Development staff for presentations at medical meetings, advisory boards and regulatory agencies
- Proactively establishes and maintains strong relationships with investigators and key opinion leaders within multiple clinical disciplines
- Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet aggressive goals
- Broad ability to analyze complex situations and propose solutions to fundamental problems leveraging drug development knowledge
- Strong leadership and people management skills that focus on teamwork and building alliances; ability to resolve conflicts and to negotiate effectively
- Strong advocate for teamwork with the initiative to develop consensus and the ability to positively manage challenge
- Ability to effectively collaborate with affiliate and contract personnel as required
- Positive approach to work and ability to inspire a sense of urgency in team members to meet timelines and project goals is required. High degree of planning ability in coordinating the activities of Clinical Development teams within the limits of clinical research schedules and ability to support aggressive timelines
- Ability to work well with outside partners, to foster collaborative team environment and to facilitate good, clear and concise communication with teams within a partnership or alliance
- Travel will be required as necessary
Preferred Skills and Experience:
- Advanced knowledge and training in clinical research, with emphasis on the medical and regulatory requirements as related to clinical research and study design. Experience across all phases of drug development is desired
- Demonstrable history of writing clinical development plans and protocols, providing medical monitoring, and direct interaction with regulatory agencies
- Exceptional presentation and oratory skills
- Experience in clinical leadership of development projects is required